臨床研究等提出・公開システム

Date of registration	Aug. 08, 2017
Last modified on	Aug. 03, 2023
Trial ID	jRCT2080223611

Scientific Title	A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination with Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects with Newly Diagnosed FLT3 ITD (+) Acute Myeloid Leukemia
Public Title	Phase 3 study of quizartinib

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Phone Number	+81-3-6225-1111
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Phone Number	+81-3-6225-1111
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Recruitment Status	completed

Date of First Enrolment		Feb. 05, 2018
Target Sample Size		35
Study Type		Interventional
Study Design	Study Design	Multi-center, double-blind, placebo-controlled
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1. Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm (at Screening) 2. Eastern Cooperative Oncology Group performance status 0-2 (at Screening)
	Exclusion Criteria	1. Diagnosis of acute promyelocytic leukemia (APL), chronic myelogenous leukemia in blast crisis 2. Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Newly diagnosed AML
Intervention(s)		investigational material(s) Generic name etc : Quizartinib INN of investigational material : Quizartinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oral administration control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Overall Survival Overall survival, defined as the time from Randomization until death from any cause
Secondary Outcome		safety efficacy pharmacokinetics pharmacodynamics Event Free Survival (EFS) EFS is defined as the time from Randomization until the date of the earliest of any of the following: 1. Refractory disease (or treatment failure) which is determined at the end of the Induction Phase 2. Relapse after CR or CRi 3. Death from any cause at any time during the study Complete Remission (CR) Rate at the End of Induction Composite CR Rate at the End of Induction, etc Percentage of Participants Achieving CR With FLT3-ITD Minimal Residual Disease Negativity Percentage of Participants Achieving Composite CR With FLT3-ITD Minimal Residual Disease Negativity, etc

Primary Sponsor	DAIICHI SANKYO CO., LTD.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	-
Address of IRB	-
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Aug. 16, 2017

Secondary ID No.	NCT02668653
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-173667
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/South America/Europe/Oceania

History of Changes

No	Publication date
12	Aug. 03, 2023	(this page)	Changes
11	April. 28, 2022	Detail	Changes
10	July. 07, 2021	Detail	Changes
9	July. 08, 2020	Detail	Changes
8	May. 29, 2020	Detail	Changes
7	Aug. 28, 2019	Detail	Changes
6	April. 15, 2019	Detail	Changes
5	Dec. 17, 2018	Detail	Changes
4	April. 20, 2018	Detail	Changes
3	April. 20, 2018	Detail	Changes
2	Aug. 08, 2017	Detail	Changes
1	Aug. 08, 2017	Detail

List of change history